Reportedly, the company became aware of certain problems with or limitations of their da Vinci device and sent out letters to “clients” (which by the way are doctors and health systems, not the patients for whom the devices are used such as me) about the issues that in some cases caused patient injuries, but messed up by not informing the FDA of the problems.

Basically they did not report adverse events, which is a serious mistake.

Some of the company’s actions may also have put children at risk as the FDA notes:

…the vagueness in the previous version of the IFU represented a health risk to pediatric patients.

I don’t think this is a major blow to ISRG, but it certainly doesn’t come at a good time and suggests some serious issues that need resolution in terms of company compliance procedures to ensure patient safety.

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Seems like Intuitive Surgical wasn’t exactly trying to hide the problems. Which is more than one can say for the Eastern Health bureaucracy up here in the Great White North…http://www.cbc.ca/news/background/cancer/misdiagnosed.html
Too bad that Eastern Health isn’t traded on the NY Stock Exchange.

I expect mistakes to happen and hope that people can be honest about them. The way I see it, overbearing bureaucracy is more a problem than a solution. So I’m not so fast to cheer every time that the FDA saddles up its white stallion and charges into the fray.